LPA1200M/52  Tendril MRI, Pacemaker Lead, 52cm  1 each

LPA1200M TENDRIL MRI Pacing Lead Tendril MRI Pacing Leads Optim ™ Ext/Ret helix 8 IS-1 bipolar 52cm

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The Tendril MRI™lead is designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible device.

Active leads such as the Tendril MRI lead may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of a screw-in lead such as Tendril MRI lead may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.

This is an MR Conditional lead.

MR Conditional Pacing System: The St. Jude Medical™ MRI conditional lead is part of the St. Jude Medical™ MRI conditional pacing system. Patients with an implanted St. Jude Medical™ MRI conditional pacing system can have an MRI scan if the conditions for use, as described in the MRI Procedure Information document, are met.

Contraindications: The Tendril MRI™ lead is contraindicated in the presence of tricuspid atresia, for patients with mechanical tricuspid valves, and in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.

Adverse Events: Potential complications associated with the use of Tendril MRI leads are the same as with the use of other active fixation leads and include: perforation of the myocardium, cardiac tamponade, phrenic nerve stimulation, dislodgement of the pacing lead, embolism, temporary or permanent loss of stimulation and/or sensing, infection, valve and/or vessel damage, tissue necrosis.